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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device test,natriuretic peptide
Regulation Description B-type natriuretic peptide test system.
Product CodeNBC
Regulation Number 862.1117
Device Class 2


Premarket Reviews
ManufacturerDecision
BAYER
  SUBSTANTIALLY EQUIVALENT 5
BIOMERIEUX
  SUBSTANTIALLY EQUIVALENT 1
DADE BEHRING
  SUBSTANTIALLY EQUIVALENT 6
I-STAT
  SUBSTANTIALLY EQUIVALENT 1
ORTHO-CLINICAL
  SUBSTANTIALLY EQUIVALENT 1
ROCHE DIAGNOSTICS CORP.
  SUBSTANTIALLY EQUIVALENT 5
SIEMENS
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Incorrect or inadequate result 32
Incorrect or inadequate test results 25
Low test results 24
False negative result 21
False positive result 5
High test results 5
Component missing 2
Device Issue 2
Low readings 1
Total Device Problems 117

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016
Class I 0 0 0 0 0 1 0 0 0 0
Class II 0 0 0 1 0 4 0 1 1 1
Class III 0 0 0 0 0 0 0 2 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Abbott Point Of Care Inc. II Aug-09-2012
2 Alere San Diego, Inc. III Jun-26-2014
3 Alere San Diego, Inc. II May-02-2014
4 Alere San Diego, Inc. I Jul-06-2012
5 Siemens Healthcare Diagnostics Inc II Jan-07-2016
6 Siemens Healthcare Diagnostics, Inc II Jun-26-2015
7 Siemens Healthcare Diagnostics, Inc III Nov-19-2014
8 Siemens Healthcare Diagnostics, Inc II Dec-11-2012
9 Siemens Healthcare Diagnostics, Inc II Sep-06-2012
10 Siemens Healthcare Diagnostics, Inc. II May-10-2012
11 Siemens Healthcare Diagnostics, Inc. II Nov-24-2010

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